RecruitingPhase 1Phase 2NCT05914116

A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors

Sponsor

DualityBio Inc.

Enrollment

862 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a phase 1/2 study testing DB-1311/BNT324, a new antibody-drug conjugate (a targeted drug that delivers chemotherapy directly to cancer cells), in people with advanced solid tumors that have stopped responding to other treatments. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor confirmed by biopsy - Your cancer has progressed after standard treatments and there are no other good options - You have good performance status and adequate organ function - You are willing to undergo tumor biopsies as part of the study **You may NOT be eligible if...** - You have untreated or unstable brain metastases - You have had significant prior toxicities from similar drug classes - You are pregnant or breastfeeding - You have active autoimmune disease on immunosuppressive therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDB-1311

Administered I.V.(intravenous infusion)

DRUGLopinavir and Ritonavir Tablets

Lopinavir and Ritonavir Tablets

DRUGitraconazole

itraconazole

DRUGEnzalutamide

oral administration

DRUGAbiraterone

oral administration

Locations(107)

Research Site 111

Tucson, Arizona, United States

Research Site 125

Los Angeles, California, United States

Research Site 133

Los Angeles, California, United States

Research Site 103

Los Angeles, California, United States

Research Site 128

Santa Monica, California, United States

Research Site 118

Celebration, Florida, United States

Research Site 127

Margate, Florida, United States

Research Site 137

Orlando, Florida, United States

Research Site 101

Plantation, Florida, United States

Research Site 109

Tamarac, Florida, United States

Research Site 114

Atlanta, Georgia, United States

Research Site 139

Atlanta, Georgia, United States

Research Site 115

Louisville, Kentucky, United States

Research Site 129

Detroit, Michigan, United States

Research Site 121

Saint Paul, Minnesota, United States

Research Site 110

Las Vegas, Nevada, United States

Research Site 107

New York, New York, United States

Research Site 138

Canton, Ohio, United States

Research Site 113

Cincinnati, Ohio, United States

Research Site 131

Dayton, Ohio, United States

Research Site 123

Charleston, South Carolina, United States

Research Site 108

Greenville, South Carolina, United States

Research Site 136

Nashville, Tennessee, United States

Research Site 135

Austin, Texas, United States

Research Site 120

Dallas, Texas, United States

Research Site 102

Fairfax, Virginia, United States

Research Site 112

Fairfax, Virginia, United States

Research Site 105

Spokane, Washington, United States

Research Site 208

Blacktown, New South Wales, Australia

Research Site 215

Camperdown, New South Wales, Australia

Research Site 212

Concord, New South Wales, Australia

Research Site 217

New Lambton Heights, New South Wales, Australia

Research Site 201

Sydney, New South Wales, Australia

Research Site 205

Sydney, New South Wales, Australia

Research Site 206

Sydney, New South Wales, Australia

Research Site 216

Waratah, New South Wales, Australia

Research Site 209

Birtinya, Queensland, Australia

Research Site 203

Brisbane, Queensland, Australia

Research Site 210

Gold Coast, Queensland, Australia

Research Site 202

Nedlands, Western Australia, Australia

Research Site 207

Nedlands, Western Australia, Australia

Research Site 319

Hefei, Anhui, China

Research Site 365

Beijing, Beijing Municipality, China

Research Site 310

Beijing, Beijing Municipality, China

Research Site 337

Beijing, Beijing Municipality, China

Research Site 327

Chongqing, Chongqing Municipality, China

Research Site 345

Chongqing, Chongqing Municipality, China

Research Site 353

Chongqing, Chongqing Municipality, China

Research Site 356

Chongqing, Chongqing Municipality, China

Research Site 313

Fuzhou, Fujian, China

Research Site 314

Guangzhou, Guangdong, China

Research Site 322

Guangzhou, Guangdong, China

Research site 367

Guangzhou, Guangdong, China

Research Site 346

Guangzhou, Guangdong, China

Research Site 348

Guangzhou, Guangdong, China

Research Site 350

Guangzhou, Guangdong, China

Research Site 360

Nanning, Guangxi, China

Research Site 334

Baoding, Hebei, China

Research Site 315

Harbin, Heilongjiang, China

Research Site 316

Luoyang, Henan, China

Research Site 317

Xinxiang, Henan, China

Research Site 306

Zhengzhou, Henan, China

Research Site 304

Zhengzhou, Henan, China

Research Site 321

Wuhan, Hubei, China

Research Site 311

Wuhan, Hubei, China

Research Site 309

Changsha, Hunan, China

Research Site 323

Changsha, Hunan, China

Research Site 344

Nanjing, Jiangsu, China

Research Site 305

Nanjing, Jiangsu, China

Research Site 307

Ganzhou, Jiangxi, China

Research Site 349

Nanchang, Jiangxi, China

Research Site 361

Nanchang, Jiangxi, China

Research Site 328

Changchun, Jilin, China

Research Site 301

Changchun, Jilin, China

Research Site 320

Shenyang, Liaoning, China

Research Site 352

Shenyang, Liaoning, China

Research Site 363

Nanjing, Nanjing, China

Research Site 340

Jinan, Shandong, China

Research Site 308

Jinan, Shandong, China

Research Site 333

Linyi, Shandong, China

Research Site 302

Linyi, Shandong, China

Research Site 335

Shanghai, Shanghai Municipality, China

Research Site 326

Shanghai, Shanghai Municipality, China

Research Site 355

Shanghai, Shanghai Municipality, China

Research Site 332

Xi’an, Shanxi, China

Research Site 312

Chengdu, Sichuan, China

Research Site 330

Chengdu, Sichuan, China

Research Site 366

Chengdu, Sichuan, China

Research Site 325

Chengdu, Sichuan, China

Research Site 347

Tianjin, Tianjin Municipality, China

Research Site 318

Tianjin, Tianjin Municipality, China

Research site 368

Tianjin, Tianjin Municipality, China

Research Site 324

Hangzhou, Zhejiang, China

Research Site 329

Hangzhou, Zhejiang, China

Research Site 331

Hangzhou, Zhejiang, China

Research Site 359

Hangzhou, Zhejiang, China

Research site 369

Hangzhou, Zhejiang, China

Research Site 303

Taizhou, Zhejiang, China

Research Site 408

Kaohsiung City, Taiwan

Research Site 405

Kaohsiung City, Taiwan

Research Site 406

New Taipei City, Taiwan

Research Site 401

Taipei, Taiwan

Research Site 402

Taipei, Taiwan

Research Site 409

Taipei, Taiwan

Research Site 403

Taipei, Taiwan

Research Site 407

Taipei, Taiwan

Research Site 404

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05914116

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